In nature, as well as in the environment created by man, we are permanently exposed to radiations such as solar, electromagnetic, and nuclear, many of which are, in different intensity, harmful to life and organism survival. However, technological advancement has allowed using the said radiations, but without eliminating their harmful components. As a result, the human body has been progressively exposed to all types of radiations, and parallel efforts have been made to improve radiation protection procedures and devices. (www.cancer.gov/cancertopics/causes/radiation-risks-pediatric-CT; www.niehs.nih.gov/oc/news/canceragents.htm; COUNCIL DIRECTIVE 97/43/EURATOM, Jun. 30, 1997).
Anatomic structures such as part of the chest, thyroids, genitals, and gonads, are highly sensitive and deeply harmed by exposure to different types of radiation. For this reason, efforts have been made to develop protection mechanisms in front of this type of radiations. Traditionally, high molecular weight metals have been applied, such as lead, as radiological protection. Lead, being an element that adds a large weight to devices to which it is incorporated, becomes of difficult application, presents certain toxic characteristics, and certain ranges of natural radioactivity. For this reason, new technologies have been developed as protection against radiation. These are products of high plasticity in their applications and easy to work with, environment friendly, and less toxic for users and operators.
Technologic solutions have been proposed, such as those described in U.S. Pat. No. 5,778,888, which proposes special radiation protection devices for men and women. However, compared to this invention, there is an outstanding difference in assigning a correct protection to properly protect the gonad region in each case. Also, fastening systems are complex and uncomfortable for the user and do not guarantee that the original position will be maintained.
On the other hand, there are proposals as the one described in U.S. Pat. No. 5,247,182, where an essentially rectangular gonad protection device is dealt with. Compared to this invention, these proposals make patients' X-ray evaluation difficult because the surface covered by these devices is larger than necessary, and it may hide areas that require be seeing and diagnosing. This way, it is possible that repeated exposures and repeated evaluations are required in order to obtain an image that meets the medical evaluation requirements. On the other hand, this invention is accurately placed on the area to be protected, minimizes the need for repeated exposures because it involves a minimum intervention of the areas that may require exposure and evaluation and, therefore, the amount of radiation on the patient decreases.
The said complications also appear in the proposal published in U.S. Pat. No. 5,523,581, where the thyroids protection device may cover a surface larger than necessary for an effective protection. This, together with the system fastening characteristics, multiplies the risk of an incorrect use; therefore, they increase the patients' risks and the possibility to repeat the evaluation.
Alternative solutions have been proposed in U.S. designs D 457,690 and D 457,689 where, in the case of men and women, respectively, gonad radiation protection devices of daily use have been published. Although the said proposal means an important contribution with regards to ease of use and devices' portability, it does not guarantee a correct positioning for a correct radiation protection, and does not guarantee their safe position which, in the case of this invention, is directly addressed and guaranteed.
Commercially, different devices are available, as those offered by Oprax Medical, MedTec, RadPad, Shielding International, QuickMedical, or Pulse Medical, although none of them has shown the technical benefits and contribution proposed by this technique. In fact, FIGS. 19-20 show that use of these devices affect the correct visualization of structures relevant for radiological diagnosis.
In pediatrics radiology literature, different important references may be found, such as the book “PRACTICAL PEDIATRIC IMAGING: DIAGNOSTIC RADIOLOGY OF INFANTS AND CHILDREN”, by DONALD KIRKS (ISBN: 0316494739), where contact gonad protection templates are described according to the patients' age (FIG. 10). As usual in medical literature, shields are described with a triangular and pointed geometric shape that increases size towards the lower end, as the arrow indicates. This means that the shield lacks an optimal shape to protect the pelvic cavity and, by being larger towards the cavity lower part, bone structures that are relevant for a medical diagnosis are covered, damaging the image quality which, in some cases, may imply repeating the examination (FIG. 18 a-b). This invention proposes a shape that has been adapted to the pelvic cavity, and its size increases the other way around, starting from its lower to its upper part, leaving the lower part free for medical diagnosis.
Currently, the shields' correct placement depends on the ability to locate the pelvic cavity through tact, as the area is invisible for the human eye. With this method, location is not accurate and many times the image quality is compromised, as important bone structures are covered for the diagnosis. This invention proposes the use an anthropometric point of reference, the pubic symphysis, which is joining through the “Anthropometric connecting point” present in the device in order to correctly place the radio/opaque material or the “radiation attenuation material” on the patient.
The present invention provides a system to protect patients from radiation providing protection to sensitive areas of the human body that are not of diagnostic interest. An example of this is to protect the reproductive glands or gonads, ovaries in girls and testes in boys, in the case of the ovaries, to take a frontal radiograph of the pelvis, the ovaries become lodged in the pelvic cavity, so you may provide protection to the pelvic cavity without obstructing bony parts of diagnostic interest, would give greater security and benefit to the patient, reducing the radiation dose in sensitive areas of the body.
Therefore, the technical solution this invention development provides aims at providing a device that offers a set of advantages and benefits with regards to technical alternatives. It is of advantage due to the flexibility and plasticity in its applications. Also, it provides a relatively high degree of comfort to the user, as well as the possibility to attenuate radiation for radiology personnel or people working with radioactive materials.
In addition, the invention offers a radiological protection system that allows incorporating beneficial qualities when operating it, such as a radiation attenuating system that may be sterilized and discarded, and complemented with other protection devices. However, the most significant contribution is accuracy and efficiency in radiological protection as a result of a precise, safe, and permanent positioning, according to the patient and/or user accurate anatomic parameter combination and adhesion and/or fastening systems.